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wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is no informa

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aptevo biotherapeutics llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated for the treatment of: - adults and children ≥ 12 years of age with hemophilia b for: on-demand treatment and control of bleeding episodes perioperative management - on-demand treatment and control of bleeding episodes - perioperative management - adults with hemophilia b for: routine prophylaxis to reduce the frequency of bleeding episodes - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated b

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takeda pharmaceuticals america, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 250 [iu] in 5 ml - rixubis (coagulation factor ix [recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes. rixubis is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . rixubis is contraindicated in patients who have: - known hypersensitivity to rixubis or its excipients including hamster protein - disseminated intravascular coagulation (dic) [see warnings and precautions (5.4)] - signs of fibrinolysis [see warnings and precautions (5.4)] risk summary there are no data with rixubis use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with rixubis. it is also not known whether rixubis can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. in the u.s. general population,

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novo nordisk - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 1 ml - rebinyn, coagulation factor ix (recombinant), glycopegylated, is a recombinant dna-derived coagulation factor ix concentrate indicated for use in adults and children with hemophilia b (congenital factor ix deficiency) for: limitations of use : rebinyn is not indicated for immune tolerance induction in patients with hemophilia b. rebinyn is contraindicated in patients who have known hypersensitivity to rebinyn or its components (including hamster proteins) [see warnings and precautions (5.1) and description (11) ] risk summary there are no data with rebinyn use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with rebinyn. it is unknown whether rebinyn can cause fetal harm when administered to a pregnant woman or can affect fertility. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no informati

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novo nordisk - coagulation factor viia recombinant human (unii: ac71r787ov) (coagulation factor viia recombinant human - unii:ac71r787ov) - coagulation factor viia recombinant human 1 mg in 1 ml - novoseven rt, coagulation factor viia (recombinant), is indicated for: none known. risk summary there are no adequate and well-controlled studies using novoseven rt in pregnant women to determine whether there is a drug-associated risk. treatment of rats and rabbits with novoseven in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. at 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. twenty-three out of 25 female rats given 6 mg per kg body weight of novoseven gave birth successfully, however, two of the 23 litters died during the early period of lactation. no evidence of teratogenicity was observed after dosing with novoseven. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is

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medexus pharma, inc. - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - ixinity, coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children ≥ 12 years of age with hemophilia b for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes ixinity is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3) ]. ixinity is contraindicated in patients who have known hypersensitivity to ixinity or its excipients, including hamster protein [see warnings and precautions (5.1) ]. risk summary there are no data with ixinity use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ixinity. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of ixinity in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ixinity and any potential adverse effects on the breastfed infant from ixinity or from the underlying maternal condition. the safety and effectiveness of ixinity in pediatric patients below the age of 12 years have not been established. clinical studies of ixinity did not include subjects aged 65 and over. it is not known whether elderly patients respond differently than younger patients. individualize dose selection for elderly patients [see dosage and administration (2.1) ]. ixinity [coagulation factor ix (recombinant)] for intravenous use after reconstitution only do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center. always follow the specific instructions given by your healthcare provider. the steps listed below are general guidelines for using ixinity. if you are unsure of the procedures, please call your healthcare provider before using ixinity. your healthcare provider will prescribe the dose that you should take. before starting reconstitution and administration you will need the following items that are included in each kit of ixinity: - one (or more) vial(s) of ixinity 250, 500, 1000, 1500, 2000, or 3000 iu powder, as prescribed by your healthcare provider - one (or more) 10 ml syringe(s), pre-filled with 5 ml of sterile water for injection (pre-filled syringe) with plunger rod attached - sterile vial adapter with filter in addition, you will need the following items that are not included in the kit: - one sterile luer-lok syringe (administration syringe); additional or larger syringes may be required if pooling multiple vials - sterile alcohol swabs - sterile infusion set - sterile gauze pad - sterile bandage ixinity is supplied in kits that include single-use vials which contain vials of ixinity (250, 500, 1000, 1500, 2000, or 3000 iu of powder), a 10 ml syringe pre-filled with 5 ml of sterile water for injection with plunger rod attached (to be used for reconstitution only), and a sterile vial adapter with filter.                             reconstitution instructions wash your hands and then clean a flat area before starting the steps for reconstituting ixinity. use an aseptic technique during reconstitution. 1. remove the pre-filled syringe and ixinity vial from storage and allow them to reach room temperature before use. check the expiration date on the ixinity vial. 2. remove the plastic cap from the ixinity vial and place the vial top up on the clean surface. you will see a rubber circle on the top of the vial.                             3. wipe the top of the ixinity vial with a sterile alcohol swab and allow it to dry. after cleaning, do not touch the rubber circle with your hands or allow it to touch another object. 4. peel back the paper cover of the vial adapter package. be careful not to touch the luer-lok (tip) in the center of the vial adapter. do not remove the adapter from the package.                             5. leave the vial adapter in the package and place it open end up on the clean surface with the luer-lok pointing up. 6. twist off the tip cap counterclockwise from the pre-filled syringe. do not touch the inside of the cap or the syringe tip.                             7. while firmly holding the package containing the adapter with one hand and the barrel of the pre-filled syringe with the other, connect the pre-filled syringe to the vial adapter by pushing the syringe tip down onto the luer-lok in the center of the vial adapter, turning clockwise until the syringe is secured.                             8. carefully lift up the combined syringe-and-vial-adapter and remove it from the plastic package and discard packaging.                             9. with one hand, continue to hold the combined syringe-and-vial-adapter. with the other hand, hold the ixinity vial tightly on the clean, flat surface. do not touch the top of the ixinity vial or the filter spike of the combined syringe and vial adapter. 10. place the vial adapter over the ixinity vial on the table; firmly push the filter spike of the vial adapter through the center of the ixinity vial rubber circle until the clear plastic cap snaps onto the ixinity vial.                             11. slowly push the plunger rod down to transfer all of the liquid from the syringe into the ixinity vial. - with the syringe and the vial still attached, gently swirl, in a circular motion, the ixinity vial until the product is fully dissolved. ixinity is a clear, colorless solution without visible particles. inspect the final solution for specks before administration. do not use contents of vial if specks or particles persist after proper reconstitution. 12. note : if you use more than one vial of ixinity per infusion, reconstitute each vial as per the previous instructions.                             13. remove the diluent syringe from the vial adapter by turning syringe counter clockwise until it is completely detached. do not touch the luer tip of the vial adapter.                             14. remove the luer-lok syringe (administration syringe) from its sterile packaging, taking care to not touch the luer tip of the syringe. attach to the reconstituted vial and vial adapter by turning syringe clockwise until it is securely attached.                             15. press and keep the plunger down and turn the ixinity vial/vial adapter/administration syringe upside down to transfer the solution. draw up the solution into the administration syringe slowly until all solution is transferred into the syringe. inspect the vial to confirm as much liquid as possible has been extracted into the administration syringe. note : if you use more than one vial of ixinity per infusion, extract reconstituted liquid from each vial, as per the previous instructions.                             16. hold onto the vial adapter with one hand and firmly grasp the administration syringe with the other and unscrew the administration syringe from the vial adapter turning either counterclockwise. do not touch the tip of the syringe to any object or surface. note: if multiple reconstituted vials are required for infusion, do not detach the large luer-lok administration syringe from the first vial until you are ready to attach the next vial (with vial adapter attached) .                             17. prior to administering the solution, invert the administration syringe so that the tip is pointed toward the ceiling and express any air in the syringe. place the administration syringe containing the ixinity solution on the clean surface, making sure that the tip does not touch anything. the reconstituted solution should be infused immediately or within 3 hours of storage at room temperature after reconstitution. note : the luer tip of the syringe must not be touched by any objects or surfaces, when disconnecting the syringe from the vial adapter, and when transferring the administration syringe to the infusion set. if you are using more than one vial, stop here and proceed to the pooling instructions. pooling instructions pooling is the process of combining two or more reconstituted vials into a larger administration syringe prior to intravenous administration. do not detach the large luer-lok administration syringe until you are ready to attach the next vial (with vial adapter attached) . follow the instructions above for reconstitution of the second vial. - remove the administration syringe from the first vial adapter by turning it counter clockwise until it is completely detached. - attach the administration syringe to the second reconstituted vial by turning clockwise until it is securely attached. - turn the ixinity vial/vial adapter/administration syringe upside down, slowly pull on the plunger rod to draw the solution into the administration syringe (see step 15 above). repeat this pooling procedure with each vial you will be using. once you have pooled the required dose, proceed to administration using the administration syringe. administration instructions for intravenous use after reconstitution only. ixinity is administered by intravenous (iv) infusion after reconstitution with diluent (sterile water for injection) supplied in the pre-filled syringe. ixinity must not be mixed with other medicinal products for infusion. reconstituted ixinity must be pulled into an administration syringe prior to infusion. ixinity is normally administered intravenously over about 5 minutes at a maximum infusion rate of 10 ml per minute. the infusion rate should be adapted to the comfort level of each patient. - attach the administration syringe containing the reconstituted ixinity solution to the luer end of the sterile infusion set. inspect for and remove any air bubbles in the infusion set and administration syringe. note : the luer tip of the administration syringe and the luer connection of the infusion set must not be touched by any object or surface, prior to connection of the administration syringe. - transfer ixinity solution into the tube by pressing the syringe plunger until the tubing is completely filled. once again, inspect for and remove any air bubbles in the infusion set and administration syringe. - perform venipuncture as directed by your healthcare provider. - limit the amount of blood entering the tubing. blood must never enter the syringe. if blood is observed in the tubing or syringe, discard all material and resume administration with a new package. - following completion of the infusion, remove the infusion set, press the sterile gauze on the infusion site until bleeding has stopped, then apply a sterile bandage. the amount of drug product remaining in the infusion set should be minimal. log the batch number of the ixinity used; it is located on the container. dispose of all unused solution, empty vials, and used needles and syringes in an appropriate container for throwing away medical waste as it may hurt others if not handled properly. contact your healthcare provider or local hemophilia treatment center if you experience any problems. ixinity® coagulation factor ix (recombinant) and any and all medexus pharma, inc. brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of medexus pharma, inc. in the united states or other countries. all rights reserved. luer-lok™ is a trademark of becton, dickinson and company. all other brand, product, service and feature names or trademarks are the property of their respective owners. manufactured by: medexus pharma, inc. chicago, il 60606 u.s. license no. 2220

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csl behring lengnau ag - albutrepenonacog alfa (unii: a57kx1vl5p) (albutrepenonacog alfa - unii:a57kx1vl5p) - albutrepenonacog alfa 250 [iu] in 2.5 ml - idelvion® , coagulation factor ix (recombinant), albumin fusion protein (rix-fp), a recombinant dna-derived coagulation factor ix concentrate, is indicated in children and adults with hemophilia b (congenital factor ix deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management of bleeding - routine prophylaxis to reduce the frequency of bleeding episodes limitations of use: idelvion is not indicated for immune tolerance induction in patients with hemophilia b. idelvion is contraindicated in patients who have had life-threatening hypersensitivity reactions to idelvion, or its components, including hamster proteins [see warnings and precautions (5.1)] . risk summary there are no data with idelvion use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted using idelvion. it is not known whether idelvion can cause fetal harm or affect reproduction capacity when administered to a pregnant woman. in the u.s. general populati

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cangene biopharma - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 5 ml

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biogen inc. - eftrenonacog alfa (unii: 02e00t2qde) (eftrenonacog alfa - unii:02e00t2qde) - eftrenonacog alfa 500 [iu] in 5 ml - alprolix, coagulation factor ix (recombinant), fc fusion protein, is a recombinant dna derived, coagulation factor ix concentrate indicated in adults and children with hemophilia b (congenital factor ix deficiency) for: - on demand treatment and control of bleeding episodes, - perioperative management of bleeding, - routine prophylaxis to reduce the frequency of bleeding episodes. limitation of use alprolix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)]. alprolix is contraindicated in individuals who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients (sucrose, mannitol, sodium chloride, l-histidine and polysorbate 20) . . pregnancy category c animal reproductive studies have not been conducted with alprolix. it is also not known whether alprolix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. alprolix should be given to a pregnant woma

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grifols usa, llc - coagulation factor ix human (unii: 6u90y1795t) (coagulation factor ix human - unii:6u90y1795t) - coagulation factor ix human 500 [iu] in 10 ml - alphanine sd is indicated for the prevention and control of bleeding in patients with factor ix deficiency due to hemophilia b. alphanine sd contains low, non-therapeutic levels of factors ii, vii, and x, and, therefore, is not indicated for the treatment of factor ii, vii or x deficiencies. this product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia a patients with inhibitors to factor viii. none known.